MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134721IL

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a pvc procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the curve of the catheter was stuck/jammed in a fully deflected position.Deflection issue.During the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received on (b)(6) 2023.The curve of the catheter was stuck / jammed in a fully deflected position.The knob/piston was unable to be turned and/or pushed up and down.No difficulty in removing the catheter.There was no ring,electrode or other physical damage observed at the distal end of the catheter.The synaptic l0 sheath was used.This event was originally considered non-reportable, however, bwi became aware the catheter was stuck/jammed in a fully deflected position on 18-oct-2023 and have reassessed the event as reportable.

Manufacturer Narrative

The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

It was reported that a patient underwent a pvc procedure with a thermocool® smart touch® sf uni-directional navigation catheter.Deflection issue.During the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received.The curve of the catheter was stuck / jammed in a fully deflected position.The knob/piston was unable to be turned and/or pushed up and down.No difficulty in removing the catheter.There was no ring, electrode or other physical damage observed at the distal end of the catheter.The synaptic l0 sheath was used.The bwi product analysis lab received the device for evaluation on 05-dec-2023.The investigation was completed on 07-dec-2023.The photo provided by the customer was inspected.Visual inspection of the photo reveals that the device is deflected (piston up); however, the curve is not fully deflected.Due to this condition, we cannot confirm a stuck condition.For further information, the physical sample will be required.The issue reported by the customer could not be confirmed during the analysis.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.No deflection stuck condition was detected.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: appropriate term/code not available (c22) / investigation conclusions: appropriate term/code not available (c22) were selected as related to the photo provided.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿catheter stuck/jammed in a fully deflected position¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18111216
• MDR Text Key: 328491788
• Report Number: 2029046-2023-02600
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134721IL
• Device Lot Number: 31114698L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNAPTIC L0 SHEATH.